Events

Retiro De Equipo (Recall) de Device Recall SpermMar Test

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Vitrolife Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    70131
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1448-2015
  • Fecha de inicio del evento
    2014-12-22
  • Fecha de publicación del evento
    2015-04-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-05-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132286
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Reagent, immunoassay, igg - Product Code KTO
  • Causa
    The firm is recalling three batches (fp14a09, fp14a10, fp14a11) of spermmar iga test due to new formulation causing the motility of sperm cells to reduce in certain samples when the new bead solution was added.
  • Acción
    FertiPro sent an Urgent: Medical Device Recall letter dated December 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to check if they have stock of the concerned lots and provide a confirmation that they have destroyed the affected products. Distributors were asked to inform their customers and instruct them to do the same. For further questions you may call (858) 824-0888.

Device

Device Recall SpermMar Test
  • Modelo / Serial
    Manufacturer's Product Number/Catalog Number: SPMA_S  Lot/Serial Number Expiration Date FP14A09 02/29/2016 FP14A10 04/30/2016 FP14A11 04/30/2016
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to the state of : OR., and Internationally to Argentina.
  • Descripción del producto
    SpermMar Test || 0.7ml Beads Particles || Label on bottle: || SpermMar Test IgA || 0.7ml Beads/Particles-50 Tests || IND REF SPMA_S || LOT Expiration || DO NOT FREEZE/NE PAS CONGELER || FertiPro N.V. || Label on box: || SpermMar || Test || IGA || 50 Determination || Test Kit || CONTENTS || 1 vial SpermMar Latex Particles 0.7 ml || REF SPMA_S || FertiPro || FertiPro N.V. || Label on box: || SpermMar || Test || IgA || 50 Determination Test Kit || Contents: 1 vial SpermMar latex particles, 0.7ml || FertiPro N.V. || For In Vitro Diagnostic || Use || SpermMar IqA Test || Manufacturer's Product Number/Catalog Number: SPMA_S || Lot/Serial Number Expiration Date || FP14A09 02/29/2016 || FP14A10 04/30/2016 || FP14A11 04/30/2016 || Product is a solution in filled into clear plastic bottles that is placed into a cardboard box. Both packages contain labeling information.
  • Manufacturer
    Vitrolife Inc

Manufacturer

Vitrolife Inc
  • Dirección del fabricante
    Vitrolife Inc, 6835 Flanders Dr Ste 500, San Diego CA 92121-3927
  • Empresa matriz del fabricante (2017)
    Vitrolife AB
  • Source
    USFDA